510(k) · Cleared
Recalled · Class I · 2025Cardiohelp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Apr 4, 2011 as substantially equivalent to K943803 (Janus Biomedical, Inc., 1996) and 12 other predicates after a 195-day review. Its family tree reaches back 9 generations to 1992. 3 of the 100 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 10 times, including a Class I recall.
- Decided
- Apr 4, 2011
- Review
- 195 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 10 (1 Class I)
- Predicates
- 13
Its longest line of descent runs back 9 generations to K922933 (1992). 97 ancestors in all, the oldest K771692 (1977). 2 later devices descend from it, 2 citing it directly. 3 of the 100 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 5 generations between
- 3 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 2 generations backK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 1 generation backK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- This deviceK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011
- Descendant · cites it directly · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK133265 Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013
Show all 9 generations
- Root · 9 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 8 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 7 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 6 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 5 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 4 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 3 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 2 generations backK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 1 generation backK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- This deviceK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −8 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −7 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −6 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −5 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −4 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −3 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| −2 | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| −1 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| 0 (this device) | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | — |
| +1 | K133598 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2014 | Class I |
| +1 | K133265 | Quadrox-IR Adult and Small Adult | Maquet Cardiopulmonary, AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 1 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTQ device
- #1 K221373 Essenz HLMscore 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (13)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943803 | Jostra HL-20 Integrated Perfusion SystemSummary page 2…MAQUET GETINGE GROUP Predicate Devices: Systems: Jostra. HL20 Integrated Perfusion System, K943803 RotaFlow Centrifugal Pump System, K991864 LIFEBRIDGE 82T, K090006 Impella 5.0 Catheters, K0831 11 Levitronix CentriMag Extracorpo… | 1996 |
| * | K991864 | Rotaflow Centrifugal Pump SystemSummary page 2…GETINGE GROUP Predicate Devices: Systems: Jostra. HL20 Integrated Perfusion System, K943803 RotaFlow Centrifugal Pump System, K991864 LIFEBRIDGE 82T, K090006 Impella 5.0 Catheters, K0831 11 Levitronix CentriMag Extracorporeal Blood Pumping System, K020271 TandemH… | 2000 |
| * | K090006 | Lifebridge B2T, Model 7001Summary page 2…GETINGE GROUP Predicate Devices: Systems: Jostra. HL20 Integrated Perfusion System, K943803 RotaFlow Centrifugal Pump System, K991864 LIFEBRIDGE 82T, K090006 Impella 5.0 Catheters, K0831 11 Levitronix CentriMag Extracorporeal Blood Pumping System, K020271 TandemHeart Escort Controller,… | 2009 |
| * | K083111 | Impella 5.0 Catheter FamilySummary page 2…Predicate Devices: Systems: Jostra. HL20 Integrated Perfusion System, K943803 RotaFlow Centrifugal Pump System, K991864 LIFEBRIDGE 82T, K090006 Impella 5.0 Catheters, K0831 11 Levitronix CentriMag Extracorporeal Blood Pumping System, K020271 TandemHeart Escort Controller, K061369 Disp~osables: RotaFlow… | 2009 |
| * | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Summary page 2…stem, K943803 RotaFlow Centrifugal Pump System, K991864 LIFEBRIDGE 82T, K090006 Impella 5.0 Catheters, K0831 11 Levitronix CentriMag Extracorporeal Blood Pumping System, K020271 TandemHeart Escort Controller, K061369 Disp~osables: RotaFlow Centrifugal Pump with Bioline Coating, K080470 Jostra OuadroxD Dif… | 2003 |
| * | K061369 | Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Summary page 2…System, K991864 LIFEBRIDGE 82T, K090006 Impella 5.0 Catheters, K0831 11 Levitronix CentriMag Extracorporeal Blood Pumping System, K020271 TandemHeart Escort Controller, K061369 Disp~osables: RotaFlow Centrifugal Pump with Bioline Coating, K080470 Jostra OuadroxD Diffusion Membrane Oxygenator with Bioline… | 2006 |
| * | K080470 | Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32, Beq-RF-32Summary page 2…1 Levitronix CentriMag Extracorporeal Blood Pumping System, K020271 TandemHeart Escort Controller, K061369 Disp~osables: RotaFlow Centrifugal Pump with Bioline Coating, K080470 Jostra OuadroxD Diffusion Membrane Oxygenator with Bioline Coating, K071 774 Ouadrox-i Adult Microporous Membrane Oxygenator with… | 2008 |
| * | K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000…Summary page 2…art Escort Controller, K061369 Disp~osables: RotaFlow Centrifugal Pump with Bioline Coating, K080470 Jostra OuadroxD Diffusion Membrane Oxygenator with Bioline Coating, K071 774 Ouadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating, K0821 17 Ouadr… | 2008 |
| * | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Summary page 2…ion Membrane Oxygenator with Bioline Coating, K071 774 Ouadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating, K0821 17 Ouadrox-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Bioline Coating, K093522 H… | 2009 |
| * | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Summary page 2…d Arterial Filter with Softline Coating, K0821 17 Ouadrox-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Bioline Coating, K093522 HLM- Tubing Set with BIOLINE Coating, K080592 HLM- Tubing Set with SOFTLINE Coating, K090533 Accessory: Venous Probe accessory (… | 2009 |
| * | K080592 | HLM Tubing Set with Bioline CoatingSummary page 2…17 Ouadrox-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Bioline Coating, K093522 HLM- Tubing Set with BIOLINE Coating, K080592 HLM- Tubing Set with SOFTLINE Coating, K090533 Accessory: Venous Probe accessory (Blood Monitoring Unit BMU4O), K090147 === Pag… | 2008 |
| * | K090533 | HLM Tubing Set with Softline CoatingSummary page 2…Oxygenator with and without Integrated Arterial Filter with Bioline Coating, K093522 HLM- Tubing Set with BIOLINE Coating, K080592 HLM- Tubing Set with SOFTLINE Coating, K090533 Accessory: Venous Probe accessory (Blood Monitoring Unit BMU4O), K090147… | 2009 |
| * | K090147 | Blood Monitoring Unit, Model Bmu 40Summary page 2…g, K093522 HLM- Tubing Set with BIOLINE Coating, K080592 HLM- Tubing Set with SOFTLINE Coating, K090533 Accessory: Venous Probe accessory (Blood Monitoring Unit BMU4O), K090147 MAQUET… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2025 | Class II | Z-1823-2025 | Under Investigation by firm | HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. |
| May 18, 2023 | Class II | Z-1643-2023 | Pending | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile… |
| May 18, 2023 | Class II | Z-1662-2023 | Under Investigation by firm | Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia. |
| Feb 8, 2019 | Class I | Z-0986-2019 | Process control | Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive. |
| Apr 4, 2018 | Class II | Z-1642-2018 | Device Design | There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. |
| Feb 23, 2016 | Class II | Z-1372-2016 | Unknown/Undetermined by firm | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. |
| Mar 5, 2015 | Class II | Z-1690-2015 | Nonconforming Material/Component | A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS… |
| Oct 17, 2014 | Class II | Z-0211-2015 | Software Design Change | Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power |
| Sep 12, 2013 | Class II | Z-0082-2014 | Software Manufacturing/Software Deployment | It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power… |
| Mar 7, 2013 | Class II | Z-1149-2013 | Software change control | It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface… |
The 5 latest of 10 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 37 of the 97 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133598 (Maquet Cardiopulmonary, AG, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K943803.
How does its category compare?
All DTQ devicesDTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DTQ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
MAUDE reports naming product code DTQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 9 | 420 |
| 2008 | 1 | — | 17 | 548 |
| 2009 | 3 | 86 | 1 | 589 |
| 2010 | 1 | — | 17 | 811 |
| 2011 | 2 | — | 22 | 1,081 |
| 2012 | 0 | — | 42 | 1,626 |
| 2013 | 0 | — | 4 | 906 |
| 2014 | 2 | — | 1 | 1,290 |
| 2015 | 2 | — | 0 | 1,184 |
| 2016 | 0 | — | 0 | 714 |
| 2017 | 2 | — | 0 | 527 |
| 2018 | 1 | — | 1 | 676 |
| 2019 | 1 | — | 1 (1) | 857 |
| 2020 | 0 | — | 0 | 627 |
| 2021 | 2 | — | 0 | 729 |
| 2022 | 0 | — | 1 | 717 |
| 2023 | 3 | 292 | 7 (1) | 818 |
| 2024 | 0 | — | 1 | 863 |
| 2025 | 0 | — | 0 | 1,014 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration…
Read the full statement (124 words)
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.
The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102726: Cardiohelp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102726
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026